SchizophreniaPhase 3RAL-S-01NCT01280305
Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder
A Phase 3 study testing raloxifene in people with Schizophrenia and Schizoaffective Disorder, run by Sheba Medical Center at 13 sites in 2 countries.
Trial summary
The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- raloxifene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post menopausal females: Post menopausal defined as: Women 45 years of age and older with no vaginal bleeding for at least 2 years prior to randomization, and both serum estradiol <73 pmol/L (20 pg/mL) and FSH >30 IU/L (30 mIU/mL).
- 45-65 years old
- Willing and able to provide informed consent, after the nature of the study has been fully explained.
- Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
- Symptoms: 4 (moderate) or above on CGI-S and 4 (moderate) score or above on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
- Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that the dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
- Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission.
Who cannot join
- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Women of child bearing potential.
- Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise
- Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
- Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy
- Likely allergy or sensitivity to raloxifene.
Show all 10Show fewer
- At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
- Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
- Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.
- Patients with hypercoaguable conditions or risk of venous thrombosis.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Romania12 sites
Clinica de Psihiatrie, Arad
Arad
Delia Podea, MD, 0722 583 757, deliapodea@gmail.com
Delia Podea, MD
Spitalul de Psihiatrie Botosani
Botoșani
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Dan Prelipceanu, MD, 0722 300 227, prelipceanudan@yahoo.com
Dan Prelipceanu, MD
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Gabriela Marian, MD, 0723 569 620, gabi.marian@yahoo.com
Gabriela Marian, MD
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Maria Ladea, MD, 0724 371 042, marialadea@gmail.com
Maria Ladea, MD
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Dorina-Valerica Sima, MD, 0723 859 570, dorinasima@yahoo.com
Dorina-Valerica Sima, MD
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Maria-Silvia Trandafir, MD, 0724 275 572, silviatrandafir2004@yahoo.com
Maria-Silvia Trandafir, MD
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Ana-Liana Giurgiuca, MD, 0722 378 967, giurgiuca_liana@yahoo.com
Ana-Liana Giurgiuca, MD
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest
Valentin Matei, MD, 0723 640 918, petcu_camelia@yahoo.com
Valentin Matei, MD
Sp. Jud. "Prof. Dr.O. Fodor"
Cluj-Napoca
Mircea-Alexandru Birt, MD, 0721 012 220, mirceabirt@yahoo.com
Mircea-Alexandru Birt, MD
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca
Ioana-Valentina Miclutia, MD, 0722 796 067, ioanamiclu@yahoo.com
Ioana-Valentina Miclutia, MD
Spitalul Clinic de Psihiatrie Socola, Iasi
Iași
Serban Turliuc, MD, 0745 203 002, serban_turliuc@yahoo.com
Serban Turliuc, MD
Israel1 site
Sheba Medical Center
Ramat Gan, 52621
Mark Weiser, MD, 972-52-666-6575, mweiser@netvision.net.il
Mark Weiser, MD
About this study
Official title: A Randomized Trial Administering Raloxifene vs Placebo as add-on to Antipsychotics in Post Menopausal Patients With Schizophrenia or Schizoaffective Disorder
The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.
Read the detailed description
Epidemiological evidence shows a potentially protective role for estrogen in women with schizophrenia. The onset of schizophrenia is later in woman than in men, with generally a less severe course until after the menopause, when for many women, reductions in estrogen levels appear to trigger an exacerbation or illness (Hafner 2003). ERα (Estrogen receptor alpha) expression is known to be reduced in schizophrenia (Wong, Woon et al. 2010). Raloxifene is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain. Several studies (Kulkarni, Riedel et al. 2001; Chua, de Izquierdo et al. 2005; Kulkarni, Gurvich et al. 2010) indicate that treatment with estrogen and raloxifene improves symptoms in females with schizophrenia, and recently they showed an improvement in PANSS score in post menopausal women with schizophrenia receiving 60-120mg/d of raloxifene compared to placebo
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- raloxifene, placebo
- Keywords
- schizophrenia, schizoaffective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raloxifeneDrug
raloxifene 60 mg bid
placeboDrug
Placebo bid
| Study group | Role | What they receive |
|---|---|---|
| raloxifene | Experimental | Not described Receives: Drug: raloxifene |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS total score at the end of the trial.
PANSS will be assesed at weeks 5, 8 and end of study.
Measured: 3 times
Secondary outcomes (1)
PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.
PANSS will be assessed at week 5, 8, and end of study; CGI-S, CGI-I, will be assessed at week 2, 5, 8, 12, and end of study; BACS will be assessed at week 8 and end of study.
Measured: PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Mark Weiser, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280305
- Sponsor's protocol ID
- SHEBA-10-8287-MW-SHEBA
- Acronym
- RAL-S-01
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2011
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiser M, Levi L, Burshtein S, Hagin M, Matei VP, Podea D, Miclutia I, Tiugan A, Pacala B, Grecu IG, Noy A, Zamora D, Davis JM. Raloxifene Plus Antipsychotics Versus Placebo Plus Antipsychotics in Severely Ill Decompensated Postmenopausal Women With Schizophrenia or Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e758-e765. doi: 10.4088/JCP.15m10498.
PubMed 28541645
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Administering Raloxifene vs Placebo as add-on to Antipsychotics in Post Menopausal Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT01280305
- Acronym / sponsor ID
- RAL-S-01 / SHEBA-10-8287-MW-SHEBA
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.
Detailed description
Epidemiological evidence shows a potentially protective role for estrogen in women with schizophrenia. The onset of schizophrenia is later in woman than in men, with generally a less severe course until after the menopause, when for many women, reductions in estrogen levels appear to trigger an exacerbation or illness (Hafner 2003). ERα (Estrogen receptor alpha) expression is known to be reduced in schizophrenia (Wong, Woon et al. 2010). Raloxifene is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain. Several studies (Kulkarni, Riedel et al. 2001; Chua, de Izquierdo et al. 2005; Kulkarni, Gurvich et al. 2010) indicate that treatment with estrogen and raloxifene improves symptoms in females with schizophrenia, and recently they showed an improvement in PANSS score in post menopausal women with schizophrenia receiving 60-120mg/d of raloxifene compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| raloxifene | Experimental | Drug: raloxifene |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Post menopausal females: Post menopausal defined as: Women 45 years of age and older with no vaginal bleeding for at least 2 years prior to randomization, and both serum estradiol <73 pmol/L (20 pg/mL) and FSH >30 IU/L (30 mIU/mL).
- 45-65 years old
- Willing and able to provide informed consent, after the nature of the study has been fully explained.
- Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
- Symptoms: 4 (moderate) or above on CGI-S and 4 (moderate) score or above on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
Key exclusion criteria (10 listed)
- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Women of child bearing potential.
- Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise
- Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
- Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| raloxifeneraloxifene 60 mg bid | Drug | raloxifene |
| placeboPlacebo bid | Drug | Placebo |
Primary outcome
PANSS total score at the end of the trial.
Time frame: 3 times
PANSS will be assesed at weeks 5, 8 and end of study.
1 secondary outcome
PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.
Time frame: PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
- Derived from this study: PubMed 28541645Weiser M, Levi L, Burshtein S, Hagin M, Matei VP, Podea D, Miclutia I, Tiugan A, Pacala B, Grecu IG, Noy A, Zamora D, Davis JM. Raloxifene Plus Antipsychotics Versus Placebo Plus Antipsychotics in Severely Ill Decompensated Postmenopausal Women With Schizophrenia or Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e758-e765. doi: 10.4088/JCP.15m10498.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Weiser, MD principal investigator
Sheba Medical Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing raloxifene in people with Schizophrenia and Schizoaffective Disorder, run by Sheba Medical Center at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Romania, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Weiser, MD (972-52-666-6575, mweiser@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS total score at the end of the trial. (time frame: 3 times). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2011.